21 CFR Part 11 jobs in Portland, OR

Remote

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2d ago

Bioinformatics Pipeline Engineer (3+ Years Exp) REMOTE We are looking to hire a candidate with the skills sets mentioned and experience for one of our clients within the life science Industry. Job Summary: We are seeking a 3+ years experience candidate with a experience in Next-Generation Sequencing (NGS) pipelines and bioinformatics workflows. The ideal candidate should have exposure to Illumina sequencing data, secondary analysis pipelines and workflow tools like Nextflow. This role focuses o

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Contract

50 - 55

Loftware Spectrum Technical Lead

Remote

•

Today

Role : Loftware Spectrum Technical Lead / Solution Engineer Position Summary Responsible for the technical design, configuration, integration, support, and lifecycle management of Integer's Loftware Spectrum enterprise labeling platform. This role serves as the primary technical resource between Labeling COE, SAP, Oracle, manufacturing sites, Quality, and implementation partners to ensure a scalable, compliant, and supportable global labeling solution. The individual will lead architecture, busi

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Third Party, Contract

Depends on Experience

Manufacturing Data Strategy & Architecture Consultant

Remote

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27d ago

Job title: Manufacturing Data Strategy & Architecture Consultant Location: Remote Position Overview Seeking a senior Manufacturing Data Strategy & Architecture Consultant to support the development of a future-state data vision, strategy, and architecture roadmap. The ideal candidate will bring deep expertise in pharmaceutical manufacturing data ecosystems, industrial data architectures, contextualization, semantics, and GxP-regulated environments. This role will serve as a trusted advisor to Pf

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Full-time, Third Party

Depends on Experience

Loftware Spectrum Technical Lead / Solution Engineer

Remote

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5d ago

At NTT DATA, we know that with the right people on board, anything is possible. The quality, integrity, and commitment of our employees have been key factors in our company's growth and market presence. By hiring the best people and helping them grow both professionally and personally, we ensure a bright future for NTT DATA and for the people who work here. For more than 25 years, NTT DATA Services have focused on impacting the core of your business operations with industry-leading outsourcing

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Contract

Depends on Experience

Equipment Engineer

Gresham, Oregon

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9d ago

Job Summary: The Equipment Engineer (Equipment Commissioning & Qualification - ECQ) supports the successful implementation, commissioning, qualification, and maintenance of equipment, instruments, facilities, and utilities in a GMP-regulated pharmaceutical environment. The role is responsible for ensuring equipment remains in a commissioned, qualified, and validated state while supporting equipment implementation projects, qualification activities, compliance, and collaboration with internal tea

Full-time

SAP Validation

Remote

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18d ago

Job Title: SAP Validation Life Sciences & Pharmaceuticals Location: Remote Duration : Long term ONLY SAP VALIDATION PROFILES Required Qualifications Bachelor s degree in computer science, Information Technology, Engineering, Life Sciences, or related field. 8+ years of experience in SAP validation or Computer System Validation (CSV). GxP regulations 21 CFR Part 11 Annex 11 GAMP 5 Experience with validation tools and documentation management systems. Familiarity with change management and deviat

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Contract

Depends on Experience

Laboratory Informatics, LIMSSubject Matter Expert - Remote

Remote

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4d ago

Laboratory Informatics | LIMS- Remote We are looking to hire a candidate with the mentioned skill sets and experience for one of our clients in the pharmaceutical Industry. This is a 6+ month contracting role, with potential for extension. Only candidates currently residing in the United States will be considered for this position.Role SummarySeeking an experienced Subject Matter Expert (SME) with 15+ years of experience in Life Sciences, Healthcare, Laboratory Informatics, and Clinical Researc

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Contract

Depends on Experience

Product Owner

Remote

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4d ago

Role OverviewThe Product Owner for the Clinical Trial Platform is responsible for defining the product vision, strategy, and roadmap for technology that supports end to end clinical trial execution.This role blends product management discipline with deep understanding of regulated clinical workflows, ensuring the platform delivers measurable value to sponsors, CROs, research sites, and patients. The PM drives feature development across study startup, patient identification, eligibility, randomiz

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Contract, Third Party

$80 - $85

Product Owner

Remote

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12d ago

Iris's direct client, a leader in Healthcare services, looking to hire a strong Product Owner for a Long-Term Contractual role Job title: Product Owner Location: 100% Remote Duration: 18 Months Skills: Product Owner, Clinical Trial Platform Job Description: Product Manager Clinical Trial Platform Role Overview The Product Manager for the Clinical Trial Platform is responsible for defining the product vision, strategy, and roadmap for technology that supports end-to-end clinical trial executio

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Contract

Depends on Experience

Clinical Trial Product Owner

Remote

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2d ago

We are hiring for a Product Owner. It s a long-term contract role // Fully Remote role. Title : Product Owner Work Schedule: Fully Remote role. Required Skills : Product Owner with Pharma or Clinical Trial Platform Please email me your resume at Role Overview The Product Owner for the Clinical Trial Platform is responsible for defining the product vision, strategy, and roadmap for technology that supports end to end clinical trial execution. This role blends product owner discipline with deep

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Full-time

Depends on Experience

Product Manager/Product Owner with Clinical Trial Platform experience.

Remote

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3d ago

Our Client which is a large Pharmaceutical Co. is urgently looking to hire Product Manager/ Product Owner with Clinical Trial Platform experience. Product Manager/Product Owner with Clinical Trial Platform experience. Location - Columbia, MD 100 % Remote. Key Skills - Product Ownership, Clinical Trials / IRB, Agile , Pharmaceutical Domain. Role Overview The Product Owner for the Clinical Trial Platform is responsible for defining the product vision, strategy, and roadmap for technology that supp

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Contract, Third Party

Depends on Experience

SAP S/4HANA Program Manager

Remote

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Yesterday

Role: SAP Program / Project ManagerLocation: Remote Key Skills: SAP S/4HANA, SAP EWM, MM, SD, PP, WM, SAP Activate, Program Governance, Cutover, Data MigrationJob OverviewWe are looking for an experienced SAP Program / Project Manager to lead large-scale SAP S/4HANA implementations, supply chain transformations, and global rollouts. The ideal resource should have strong experience managing cross-functional teams, system integrators, project governance, risks, budgets, and delivery timelines acro

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Contract

Depends on Experience

SAP S/4HANA Program / Project Manager

Remote

•

Yesterday

Job Description: SAP S/4HANA Program / Project ManagerExperience: 12+ Years Role: SAP Program / Project Manager Key Skills: SAP S/4HANA, SAP EWM, MM, SD, PP, WM, SAP Activate, Program Governance, Cutover, Data Migration Job Overview : We are looking for an experienced SAP Program / Project Manager to lead large-scale SAP S/4HANA implementations, supply chain transformations, and global rollouts. The ideal resource should have strong experience managing cross-functional teams, system integrator

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Third Party, Contract

Depends on Experience

Loftware Spectrum Technical Lead / Solution Engineer @ Remote

Remote

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5d ago

Position: Loftware Spectrum Technical Lead / Solution Engineer Location: Remote Duration: 6+ months Job Description: Position Summary Responsible for the technical design, configuration, integration, support, and lifecycle management of Integer's Loftware Spectrum enterprise labeling platform. This role serves as the primary technical resource between Labeling COE, SAP, Oracle, manufacturing sites, Quality, and implementation partners to ensure a scalable, compliant, and supportable g

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Contract, Third Party

Depends on Experience

Sr. Clinical Developer/ SME (R+Clinical)

Remote or Hybrid in Tampa, Florida

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3d ago

Hi, Job DetailsPosition: Senior Clinical Developer/SME (R + Clinical)Location: Anywhere on the U.S. East CoastExperience Required: 8+ years of deep R programming experiencePrimary Skills: R, Pharmacokinetics (PK/PD), Clinical Data Processing, CDISC SDTM/ADaMKey Technologies: R Shiny, tidyverse, data.table, PKNCA, mrgsolve, rxode2Clinical Modeling Tools: NONMEM, Monolix, Phoenix WinNonlinReporting Tools: R Markdown, QuartoWork Arrangement: HybridRole OverviewWe are seeking an experienced Senior C

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Contract, Third Party

65 - 70

Loftware Spectrum Technical Lead

Remote

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4d ago

Hello, We have an opening for the role mentioned below with Our client. Please review the job description and let me know if it aligns with your experience and interests. If so, kindly share your updated resume. Thank you. Loftware Spectrum Technical Lead / Solution Engineer Remote Position Summary Responsible for the technical design, configuration, integration, support, and lifecycle management of Integer's Loftware Spectrum enterprise labeling platform. This role serves as the prima

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Contract, Third Party

Depends on Experience

Planisware PPM Administrator w/ Power BI

Remote

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Today

Systems / Data Analyst Location: Remote (Easter Time Zone) Contract Duration: 12 Months plus Start Date: ASAP About the Role Our client is seeking an experienced Systems / Data Analyst to support its Technical Services organization within the pharmaceutical and life sciences industry. This position will serve as the primary Planisware System Administrator, with responsibility for platform configuration, governance, user access, and ongoing enhancements. The Systems / Data Analyst will also d

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Contract

Sr SampleManager Implementation Engineer

Remote or Indiana

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Today

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Senior SampleManager LIMS Implementation Engineer How will you make an impact? As a Senior SampleManager LIMS Implementation Engineer, you will be a technical expert responsible for the configuration, implementation, integration, and deployment of Thermo Scientific SampleManager LIMS solutions. This role is highly hands-on and focused on translating defined laboratory processes and solution designs into robus

Full-time

USD 93,800.00 - 140,675.00 per year

Clinical Biometrics Data Engineer

Remote

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3d ago

Clinical Data Business Analyst Biometrics & Data Engineering Role OverviewThis role is the connective tissue between Biometrics and Data Engineering. It exists because clinical data has meaning that structure alone doesnt carry: someone has to understand what the data represents clinically, what the standards require of it, and how it must therefore be modeled and then make sure the engineering team builds systems that produce it correctly. The SME owns that translation. They bring clinical dat

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Contract

Depends on Experience

GxP Systems and Support Administrator

Remote

•

Today

Are You Ready? CAI is a professional services company established in 1996 that has grown year over year to nearly 800 people worldwide. For mission-critical and regulated industries that need to deliver critical solutions in high-stakes environments, we provide accelerated operational readiness and unparalleled performance at the highest standard through our rigorous approach, field-tested processes, and elite expertise developed over 30 years. Our approach is simple because our Purpose inform

Full-time

USD 130,000.00 - 150,000.00 per year

21 CFR Part 11 jobs in Portland, OR, USA